# FDA recall Z-1322-2024

> **Thommen Medical AG** · Class II · device recall initiated 2024-01-24.

## Product

impression coping, repositionable, short, screw-retained, PF 4.0

## Reason for recall

The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.

## Distribution

US Nationwide distribution in the states of OH and KY.

## Key facts

- **Recall number:** Z-1322-2024
- **Recalling firm:** Thommen Medical AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-24
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bettlach, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2024

## Citation

> AI Analytics. FDA recall Z-1322-2024. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1322-2024. Source: US FDA. Licensed CC0.

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